Value of Information Methods for NHLBI Trials

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 DESCRIPTION (provided by applicant): NHLBI faces major challenges in determining how best to allocate investment in randomized clinical trials (RCTs). Currently, there is no consistent mechanism to evaluate and compare proposed RCTs for NHLBI to best determine where to invest its limited dollars. Novel approaches in decision science can provide valuable information to enhance the RCT prioritization process at NHLBI. The overall objective of this project is to develop a comprehensive toolkit of pragmatic value of information (VOI) approaches and the corresponding software that can be readily used by clinical researchers and funders in order to assess the value of RCTs related to heart, lung and blood diseases. In addition, we will develop standardized tables that would report each component of these calculations for an RCT to improve transparency and communication of the results. Using these methods, one can estimate the value of a perfect study that would eliminate all uncertainty and be translated immediately. Such an estimate would provide an upper bound to the value of the RCT. Alternatively; one can estimate the value of an RCT with a proposed design that would partially eliminate uncertainty. In other applications, one can derive optimal sample sizes or compare alternative designs (e.g. adaptive versus traditional) for a proposed study. Such information and presentations of expected risk and value from different RCT investments can help NHLBI with a quantitative visualization of its investment portfolio and optimize that portfolio over time.